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WO2014066468A8 - Formulation d'anticorps, stable, à faible viscosité - Google Patents

Formulation d'anticorps, stable, à faible viscosité Download PDF

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Publication number
WO2014066468A8
WO2014066468A8 PCT/US2013/066313 US2013066313W WO2014066468A8 WO 2014066468 A8 WO2014066468 A8 WO 2014066468A8 US 2013066313 W US2013066313 W US 2013066313W WO 2014066468 A8 WO2014066468 A8 WO 2014066468A8
Authority
WO
WIPO (PCT)
Prior art keywords
stable
low viscosity
antibody
antibody formulation
formulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2013/066313
Other languages
English (en)
Other versions
WO2014066468A1 (fr
Inventor
Jared BEE
Paul SANTACROCE
Jiali DU
Mariana Dimitrova
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MedImmune LLC
Original Assignee
MedImmune LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by MedImmune LLC filed Critical MedImmune LLC
Priority to MX2015004668A priority Critical patent/MX2015004668A/es
Priority to RU2015119547A priority patent/RU2015119547A/ru
Priority to CA2885862A priority patent/CA2885862A1/fr
Priority to CN201380055029.3A priority patent/CN104768578A/zh
Priority to BR112015008186A priority patent/BR112015008186A2/pt
Priority to HK15112690.1A priority patent/HK1211840A1/xx
Priority to AU2013334740A priority patent/AU2013334740A1/en
Priority to JP2015539744A priority patent/JP2015536934A/ja
Priority to SG11201502659YA priority patent/SG11201502659YA/en
Priority to EP13848584.2A priority patent/EP2911693A4/fr
Priority to KR1020157013150A priority patent/KR20150070384A/ko
Priority to HK16102332.5A priority patent/HK1214499A1/zh
Priority to US14/437,585 priority patent/US20150239970A1/en
Publication of WO2014066468A1 publication Critical patent/WO2014066468A1/fr
Publication of WO2014066468A8 publication Critical patent/WO2014066468A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • C07K16/248IL-6
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une formulation d'anticorps, stable, à faible viscosité, la formulation comprenant une concentration élevée d'anticorps anti-IL6. Dans certains modes de réalisation, l'invention concerne une formulation d'anticorps, stable, à faible viscosité comprenant environ 50 mg/mL à environ 400 mg/mL d'un anticorps anti-IL6, et de l'arginine, la formulation d'anticorps étant dans une solution aqueuse et ayant une viscosité de moins de 20 cP à 23°C. L'invention concerne également des procédés de fabrication et des procédés d'utilisation de telles formulations d'anticorps.
PCT/US2013/066313 2012-10-25 2013-10-23 Formulation d'anticorps, stable, à faible viscosité Ceased WO2014066468A1 (fr)

Priority Applications (13)

Application Number Priority Date Filing Date Title
MX2015004668A MX2015004668A (es) 2012-10-25 2013-10-23 Formulacion estable de anticuerpos de baja viscosidad.
RU2015119547A RU2015119547A (ru) 2012-10-25 2013-10-23 Стабильный низковязкий состав с антителом
CA2885862A CA2885862A1 (fr) 2012-10-25 2013-10-23 Formulation d'anticorps, stable, a faible viscosite
CN201380055029.3A CN104768578A (zh) 2012-10-25 2013-10-23 稳定的低粘度抗体配制品
BR112015008186A BR112015008186A2 (pt) 2012-10-25 2013-10-23 formulação de um anticorpo estável e de baixa viscosidade
HK15112690.1A HK1211840A1 (en) 2012-10-25 2013-10-23 Stable, low viscosity antibody formulation
AU2013334740A AU2013334740A1 (en) 2012-10-25 2013-10-23 Stable, low viscosity antibody formulation
JP2015539744A JP2015536934A (ja) 2012-10-25 2013-10-23 安定した低粘度の抗体製剤
SG11201502659YA SG11201502659YA (en) 2012-10-25 2013-10-23 Stable, low viscosity antibody formulation
EP13848584.2A EP2911693A4 (fr) 2012-10-25 2013-10-23 Formulation d'anticorps, stable, à faible viscosité
KR1020157013150A KR20150070384A (ko) 2012-10-25 2013-10-23 안정한 저점도 항체 제제
HK16102332.5A HK1214499A1 (zh) 2012-10-25 2013-10-23 穩定的低粘度抗體配製品
US14/437,585 US20150239970A1 (en) 2012-10-25 2013-10-23 Stable, Low Viscosity Antibody Formulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261718379P 2012-10-25 2012-10-25
US61/718,379 2012-10-25

Publications (2)

Publication Number Publication Date
WO2014066468A1 WO2014066468A1 (fr) 2014-05-01
WO2014066468A8 true WO2014066468A8 (fr) 2015-04-09

Family

ID=50545202

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/066313 Ceased WO2014066468A1 (fr) 2012-10-25 2013-10-23 Formulation d'anticorps, stable, à faible viscosité

Country Status (13)

Country Link
US (1) US20150239970A1 (fr)
EP (1) EP2911693A4 (fr)
JP (1) JP2015536934A (fr)
KR (1) KR20150070384A (fr)
CN (2) CN104768578A (fr)
AU (1) AU2013334740A1 (fr)
BR (1) BR112015008186A2 (fr)
CA (1) CA2885862A1 (fr)
HK (2) HK1214499A1 (fr)
MX (1) MX2015004668A (fr)
RU (1) RU2015119547A (fr)
SG (1) SG11201502659YA (fr)
WO (1) WO2014066468A1 (fr)

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BR112015010360A8 (pt) 2012-11-08 2018-01-16 Eleven Biotherapeutics Inc antagonistas de il-6 e utilização dos mesmos.
WO2014186350A1 (fr) * 2013-05-15 2014-11-20 Medimmune Limited Purification de polypeptides produits par recombinaison
CA3198322A1 (fr) 2014-05-15 2015-11-19 Rani Therapeutics, Llc Compositions pharmaceutiques et procedes de fabrication de masses solides comprenant des polypeptides et/ou des proteines
US11548940B2 (en) 2014-05-15 2023-01-10 Rani Therapeutics, Llc Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
TWI694836B (zh) 2014-05-16 2020-06-01 英商葛蘭素史克智慧財產管理有限公司 抗體調配物
ES2600488T3 (es) 2014-05-23 2017-02-09 Ares Trading S.A. Composición farmacéutica líquida
EP2946766B1 (fr) 2014-05-23 2016-03-02 Ares Trading S.A. Composition pharmaceutique liquide
ES2607489T3 (es) 2014-05-23 2017-03-31 Ares Trading S.A. Composición farmacéutica líquida
UA122673C2 (uk) 2014-11-07 2020-12-28 Елевен Байотерапьютікс, Інк. Антитіло, що специфічно зв'язується з людським il-6
EP3294273A4 (fr) * 2015-05-08 2018-12-05 Incube Labs, LLC Préparations d'anticorps anti-interleukines à administrer dans la lumière du tractus intestinal au moyen d'un dispositif d'administration pharmacologique à avaler
BR112018001853A2 (pt) * 2015-07-31 2018-09-25 Astrazeneca Pharmaceuticals Lp métodos para tratamento de um distúrbio e para melhoria do tratamento de um distúrbio
KR20240090616A (ko) * 2015-08-19 2024-06-21 아스트라제네카 아베 안정한 항-ifnar1 제형
JP2019510078A (ja) 2016-02-23 2019-04-11 セセン バイオ, インコーポレイテッド Il−6アンタゴニスト製剤およびその使用
JP7541810B2 (ja) 2016-03-03 2024-08-29 リジェネロン・ファーマシューティカルズ・インコーポレイテッド Angptl3阻害剤と組み合わせてpcsk9阻害剤を投与することにより高脂血症を有する患者を処置するための方法
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SI3479819T1 (sl) * 2016-06-30 2024-06-28 Celltrion Inc. Stabilen tekoči farmacevtski pripravek
CN109803640B (zh) * 2016-08-10 2022-01-04 赛特瑞恩股份有限公司 稳定的液体抗流感病毒抗体医药调配物
KR102546471B1 (ko) * 2016-09-27 2023-06-21 프레제니우스 카비 도이치란트 게엠베하 액상의 약학 조성물
CN118359705A (zh) 2016-10-19 2024-07-19 英温拉公司 抗体构建体
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KR102312222B1 (ko) 2016-12-22 2021-10-12 우니베르시따 델리 스투디 만냐 그레챠 카탄차로 Cd43의 독특한 시알로글리코실화된 암-연관 에피토프를 표적으로 하는 모노클로날 항체
TW202444416A (zh) 2017-02-01 2024-11-16 耶魯大學 心臟衰竭及心腎症候群之精準治療
MX2019010282A (es) * 2017-03-01 2020-01-09 Medimmune Ltd Formulacion de anticuerpos monoclonales.
EP3624846B1 (fr) 2017-05-16 2024-08-07 Bhami's Research Laboratory, Pvt. Ltd. Formulations de protéines à haute concentration ayant une viscosité réduite incluant une mixture d'acide nicotinique et tryoptophane
WO2019136312A1 (fr) 2018-01-05 2019-07-11 Corvidia Therapeutics, Inc. Méthodes de traitement d'une inflammation médiée par il-6 sans immunosuppression
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Also Published As

Publication number Publication date
RU2015119547A (ru) 2016-12-20
CA2885862A1 (fr) 2014-05-01
EP2911693A4 (fr) 2016-04-27
KR20150070384A (ko) 2015-06-24
WO2014066468A1 (fr) 2014-05-01
CN106421782A (zh) 2017-02-22
AU2013334740A8 (en) 2015-04-09
BR112015008186A2 (pt) 2017-09-19
HK1211840A1 (en) 2016-06-03
US20150239970A1 (en) 2015-08-27
SG11201502659YA (en) 2015-05-28
CN104768578A (zh) 2015-07-08
MX2015004668A (es) 2015-07-23
AU2013334740A1 (en) 2015-04-02
EP2911693A1 (fr) 2015-09-02
HK1214499A1 (zh) 2016-07-29
JP2015536934A (ja) 2015-12-24

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